1. S.P. SHANI TECHNICAL OFFICER (Drugs) CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (DIRECTORATE GENERAL OF HEALTH SERVICES) MINISTRY OF HEALTH & FAMILY WELFARE, NEW DELHI

4. Surveillance of Adverse Event following Immunization ( Regulatory Issues)

17. CDL is responsible for Pre-release Certification of Vaccine in the Country

22. HOW THE ADVERSE EVENTS ARE REPORTED AND INVESTIGATED

23. COORDINATION ACTIVITIES AT THE LEVEL OF DCGI DURING REPORTING OF ADVERSE EVENTS DCGI Reporting of Adverse Events State Licensing Authority Zonal Office of CDSCO STATE EPI CDL Statutory Action Manufacture r

38. THANK YOU - National Childhood Vaccine Injury Act of the Public Health Service. Section 2125, 1986; codified at 42 USC Section 300aa-26 - CDC, Food and Drug Administration. Vaccine Adverse Reporting System: updated reportable events table. - Stetler HC, Mullen JR, Brennan J-P, Livengood JR, Orenstein WA, Hinman AR. Monitoring system for adverse events following immunization. Vaccine 1987;5:169--74. - Faich GA. Adverse-drug-reaction monitoring. New Engl J Med 1986;314:1589--92. - Chen RT, Rastogi SC, Mullen JR. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12:542--50. - Braun MM, Ellenberg SS. Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991--1994. J Pediatr 1997;131:529--35. - Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT, VAERS Working Group. An overview of the Vaccine Adverse Event Reporting System (VAERS) as a surveillance system. Vaccine 1999;17:2908--17. - Varricchio FE. The Vaccine Adverse Event Reporting System. J Toxicol Clin Toxicol 1998;36:765--8. - Food and Drug Administration. 21 CFR Part 600.80. Postmarketing reporting of adverse experiences. Federal Register 1997;62:52252--3. - World Health Organization. Side effects: adverse reaction. Geneva, Switzerland: National Centres participating in the WHO International Drug Monitoring Programme, September 1991.. - SAS Institute Inc. SAS/STAT® user's guide. Version 6, 4th ed. Cary, NC: SAS Institute Inc, 1989. - Silvers LE, Ellenberg SS, Wise RP, Varricchio FE, Mootrey GT, Salive ME. The epidemiology of fatalities reported to the Vaccine Adverse Event Reporting System 1990--1997. Pharmacoepidemiology and Drug Safety 2001;10:279--85. - Fleming PJ, Blair PS, Platt MW, et al. The UK accelerated immunisation programme and sudden unexpected death in infancy: case-control study. BMJ 2001;322:822--5. - Institute of Medicine. Adverse effects of pertussis and rubella vaccines: a report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. Howson CP, Howe CJ, Fineberg HV, eds. Washington, DC: National Academy Press, 1991:125--43. - Griffin MR, Ray WA, Livengood JR, Schaffner W. Risk of sudden infant death syndrome after immunization with the diphtheria-tetanus-pertussis vaccine. New Engl J Med 1988;319:618--23. - Hoffman HJ, Hunter JC, Damus K, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death: results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome Risk Factors. Pediatrics 1987;79:598--611. - Institute of Medicine. Adverse events associated with childhood vaccines: evidence bearing on causality. Stratton KR, Howe CJ, Johnston RB, Jr, eds. Washington, DC: National Academy Press, 1994:274--304.